Class 2 Device Recall Disposable AEM Cord

• Date Initiated by Firm: July 09, 2004
• Date Posted: July 22, 2004
• Recall Status: Terminated on December 14, 2004
• Recall Number: Z-1132-04
• Recall Event ID: 29563
• 510(K)Number: K913625
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Encision ES4107 Disposable AEM Cord, Sterile.
• Code Information: REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
• Recalling Firm/ Manufacturer: Encision, Inc.; 4828 Sterling Dr; Boulder CO 80301-2350
• For Additional Information Contact: 303-444-2600
• Manufacturer Reason for Recall: Firm found pinholes in packaging which would compromise sterility.
• FDA Determined Cause: Other
• Action: Affected customers were notified by fax or mail on 7/15/2004.
• Quantity in Commerce: 73 units
• Distribution: AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI